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FDA 510(k)

A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)

K-Number: K111166 · 2011-09-08

ApplicantSpineworks, LLC
Decision Date2011-09-08
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.) is the device name listed in this FDA 510(k) record. The listed applicant is Spineworks, LLC. It received FDA 510(k) clearance on 2011-09-08 under 510(k) number K111166. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)?

A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.) is a medical device that received FDA 510(k) clearance on 2011-09-08. The listed applicant is Spineworks, LLC. The 510(k) number is K111166.

When did A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.) receive FDA 510(k) clearance?

A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.) received FDA 510(k) clearance on 2011-09-08, under 510(k) number K111166.

Who is the listed applicant for A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)?

The FDA 510(k) record lists Spineworks, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)?

The FDA product code for A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.) is MAX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Spineworks, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K081331FIXXSURE CROSS LINKK042600STANSION MATRIX

Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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